Conbercept, Polypoidal Choroidal Vasculopathy
Conditions
Keywords
registration study, Polypoidal Choroidal Vasculopathy, Conbercept
Brief summary
1. To evaluate the effectiveness of Conbercept for PCV patients. 2. To describe the characteristics of PCV. 3. To describe the adverse events (AE) of Conbercept in the treatment of PCV. 4. Todescirbe the real situation and prognosis of PCV patients in our country.
Detailed description
1. To observe the visual changes in PCV patients receiving Conbercept treatment, so as to evaluate the effectiveness of the treatment. Changes of OCT, ICGA, quality of life and visual function would be observed and evaluated. 2. To observe and describe the characteristics of PCV. 3. To observe and describe the incidence of adverse events (AE) and serious adverse events (SAE) of Conbercept in the treatment of PCV, so as to evaluate the safety of this treatment. 4. To observe and descirbe the real situation and prognosis of PCV patients in our country.
Interventions
DRUGConbercept
Intravitral injection of Conbercept (0.5 mg/0.05 mL, Chengdu Kanghong Biotech, Inc.)
Sponsors
Peking Union Medical College Hospital
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* According to the current diagnostic criteria, diagnosed as PCV patients * Conbercept is used for treatment, and the recommended treatment scheme is 3+PRN * Local and systemic anti-VEGF therapy was not used for at least three months before enrollment * The patient volunteers to take part in this observational study, and signs the informed consent * The patient can follow-up regularly (at least 4 times of follow-up in one year)
Exclusion criteria
* The patient has serious systemic disease, and the current clinical treatment is contraindicated * Local or systemic anti-VEGF therapy was used for less than three months before enrollment * Existence of diseases unsuitable to accept intravitreal Conbercept, including uncontrolled hypertension and diabetes, AIDS, malignant tumors, active hepatitis, severe renal failure, severe mental, nerve, cardiovascular, respiratory and immune diseases * During six months before screening, there were cardiovascular events such as stroke, transient ischemic attack, myocardial infarction or acute congestive heart failure * Ocular contraindications, including active intraocular inflammation, infectious endophthalmitis, corneal ulcer, scleritis, uncontrolled glaucoma and so on * Patients who could not follow up regularly * Patients who refuse to sign the informed consent * Others
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual acuity | 6 months after the first Conbercept treatment | Best corrected visual acuity using ETDRS chart (letter numbers) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| FFA&ICGA | 12 months after the first Conbercept treatment | Changes of PCV lesions on ICGA (μm) |
| OCT and OCTA | 12 months after the first Conbercept treatment | Changes of central retinal thickness and size of PED (μm) |
Countries
China
Outcome results
None listed